Speakers (22)
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Jacques Dysli
Head, Biotech Supply Chain
Merck Serono
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The merger of Merck and Serono required the integration of two different sales and operations planning approaches. This session will discuss Merck Serono's 'Godfather initative' implemented to reconstruct their supply chain network and integrate a push system with a pull system. This initative has been key in maintaining high customer service levels and has highlighted the importance of sales forecast accuract within the commercial organisation ...more
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Dr Graham Cook
Senior Director, Process Knowledge / Quality by Design
Wyeth
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The new paradigm of Quality by Design, as described in the ICH Q8(R1), Q9 and Q10 guidance documents, presents a tremendous opportunity for the pharmaceutical industry to improve manufacturing efficiencies and enhance the assurance of quality. This presentation will describe Quality by Design, show how PAT is complementary, and why this is a win-win-win for industry, regulators and patients. The application of QbD principles to gain product and p ...more
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Dolf Gijtenbeek
Director, Strategic Sourcing
Schering Plough
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The challenges in the global economy are not only affecting the pharmaceutical industry but is also causing problems for its' suppliers. Material shortages as a result of supplier bankruptcy or knock on effects from other indutries can seriously affect plant productivity due to a lack of supplies. This session will discuss how Schering Plough overcame the shortage of a critical solvent to avoid an impact on API supply. It was also look at the ...more
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Peter McDonnell
Senior Technical Director
Genzyme
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This session will discuss Genzyme's continuous processing plant. The plant has a capacity >500 tons per year. It incorporates Nitech tubular baffled reactor technology instead of traditional high pressure batch reactors. This session will discuss the benefits of the continuous plant including lower costs, speed of construction, low footprint and ease of adding further capacity if required. The plant has been through successful pre-approval inspe ...more
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Andrew Teasdale
Senior QA Executive & Chair, Genotoxic Impurities Advisory Group
AstraZeneca
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This presentation will focus on the impact that the EMEA guideline on genotoxic impurities has had on the Pharmaceutical Industry and in particular on process development, and will outline a strategy to allow the risk posed by such impurities to be effectively managed.
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Liam Dunne
Director, Process Development and Commercialisation
Merck Sharp & Dohme Ltd
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This presentation will cover an overview of Merck's 'Commercialization Model' which helps accelerate new products through late stage clinical phases onto the market whilst minimizing at risk capital spend, using fungible resources, mitigating technical and scale-up risk and maximizing launch process capability. It will also include examples of how through a combination of organizational alignment, technical capability enhancement and the applica ...more
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Valerio Trifoni
Finance and Controlling Director, Technical Operations
Ferring Pharmaceuticals
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Valerio Trifoni is currently Finance and Controlling Director of Technical Operations in Ferring. This presentation will discuss the impact of product development and the manufacutring network on cost of goods sold. In an economy where pharmaceutical companies are under pressure to save money and to reduce the cost of goods financial decisions in the development phase and manufacturing network can significantly reduce the cost of goods sold stru ...more
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Gerald Heddell
Director, Inspection and Enforcement
MHRA
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The MHRA is the regulatory agency for the pharmaceutical industry in the UK, responsible for ensuring compliance across manufacturing sites. Gerald Heddell is Director of the Inspectiona nd Enforcement team and will discuss how the regulators can help the industry to develop excellence in their operations.
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Dr Justin O. Neway
Executive Vice President & Chief Science Officer
Aegis Analytical Corporation
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Quality by Design (QbD) starts in process development. This is where the best opportunity exists to design improved processes based on new process measurements and by taking advantage of previous experiences with similar processes. With the introduction of Process Analytical Technology (PAT) as a tool for achieving QbD in pharmaceutical and biotechnology processes, the volume of electronic and paper-based data collected during process developme ...more
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Giovanni Polvani
COO
JMAC EUROPE b.v.
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Giovanni Polvani was born in Genoa and is 49 years old. He Graduated in 1986 as Mechanical Engineer, specialised in Thermodynamics of Nuclear Plant, got 1st employment in Planning and logistics in a Petrochemical Plant ( ERG Petroli ). He joined JMAC in 1989, at very early start up of European operations and is today is COO of Jmac Europe B.V. , coordinating 6 JMAC offices in Europe and managing cross business development. He is a Senior Consulta ...more
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Klaus Köhler
Industry Manager, Life Sciences
Endress+Hauser
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Shorter times to market, fast-track-projects and shorter plant life-cycles are getting a bigger challenge in the Life Science industry. This workshop demonstrates how a qualified industry specialist and instrumentation/automation one-stop-shop can help reduce time to production and increase plant efficiency and quality at the same time. New technologies for instrumentation and process analytics support faster qualification in a regulated environm ...more
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Dr Christoph Ebensperger
Principal, Head of Business Segment Life Sciences
Horvath & Partners
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Christoph Ebensperger is head of the company’s Business Segment Life Science. As a consultant, he has helped clients in the pharmaceutical industry. Assignments included many optimization initiatives in operations and supply chain management. He recently completed two benchmarking studies on pharmaceutical technical operations. Prior to working as a consultant, Christoph gained experience in the pharmaceutical and biotechnology industry.
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Olivia Darmuzey
QbD Expert, Pharmaceutical Operations
Novartis Pharma Stein AG
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Mark B. Hassenplug
Global Life Sciences Business Advisory and Supply Chain Leader
Ernst & Young
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Mark is a Principal in Ernst & Young's Business Advisory Services practice and is the Global Life Sciences Advisory and Supply Chain Management Leader. He has more than 24 years of management consulting and business advisory services experience in the areas of strategic planning, business transformation, supply chain and manufacturing operations, customer relationship management, shared services design/implementation and enterprise resource plan ...more
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Adam Buckley
Shingo Prize for Operational Excellence
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Christophe Carnewal
Head, Technical Services
Baxter BioScience
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Marty Boom
Principal
WCI Consulting Ltd
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Marty joined WCI in 1997 and, for the last twelve years, he has managed and led global business improvement assignments in the Life Sciences industry. Marty is an expert manager of change in strictly regulated environments and is WCI’s Lean Compliant Operations proposition owner. Key areas of expertise include:  Large Programme Management  Change Management  Lean Compliance  Lean Operations ... more
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Lex van Paassen
Manager, Global External Manufacturing QA EMEA/Qualified Person, Global Pharmaceutical Supply Group GPSG
Centocor
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The complexity of the manufacture of biologicals sets high standards for quality oversight. The various steps in the upstream, downstream and fill & finish process may take place at different locations around the globe and should be properly managed. The various locations, (company) cultures and quality standards present multiple challenges to assure a uniform quality of the product. Already during the phase of the technical transfer of a pro ...more
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Dr. Reg Shaw
Former Managing Director
Wyeth Biotech
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Currently Chairman of Health Research Board, Ireland, board member of companies in Ireland/UK, including Chairman of Excelsyn Ltd., a leading supplier of active intermediates to the pharmaceutical industry. In addition, Dr. Shaw acts as consultant to various world leading companies and serves on various Irish Government agencies. From 1999 to 2007, as Managing Director of Wyeth, Ireland, he had overall responsibity for one of the world’s l ...more
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Dr. Thurloch O' Criodain
Head of Quality, Pharma Ops
Novartis Pharma AG
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Dr. O'Criodain has been working in Quality Management since 1980. He began his career with Abbott Laboratories in the area of medical devices. After working with some smaller device and pharmaceutical companies, he joined Wyeth in 1992 as Director of Quality at their tablet manufacturing site in Ireland. From 1998 to 2005, he worked in their European office, first as Director of Quality for Europe, Middle-Ease and Africa, and later as Internation ...more
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Patrick Donovan
Director, Application Development
CambridgeSoft
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Drug manufacturers face complex challenges the development and execution of manufacturing operations. In this workshop, we will discuss our end-to-end approach to streamline the management of the manufacture of pharmaceuticals using CambridgeSoft’s industry leading suite of applications. We will cover process development and batch sheet execution, template management, documentation of materials and equipment used using the GxP compliant ...more
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Ron Kasner
VP, Corporate Development
LabVantage Solutions, Inc
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JohnsonDiversey’s Global Results Driven Supplier Development (RDSD) program is designed to identify and pursue improvement initiatives with selected suppliers across major spend categories. This initiative includes Supplier Performance Management (SPM) within the enterprise Quality Management System (eQMS) and Global Strategic Sourcing strategy. The objectives of robust SPM are to continuously track selected key performance indicators (KP ...more
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